Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— FACT  

Official title:

Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD: a Randomised, Open-label, Multicentre Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03258749
• Other study ID #: KY2017-009
• Status: Not yet recruiting
• Phase: N/A
• First received: August 13, 2017
• Last updated: October 18, 2017
• Start date: November 1, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: October 2017
• Source: Huashan Hospital
• Contact: Shengqing Li, PhD
• Phone: +8602152887072
• Email: shengqingli[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic obstructive pulmonary disease (COPD) is a disease state characterized by persistent airflow limitation and associated with an accelerated decline in lung function, impaired quality of life, hospitalization, and increased mortality. As a major public health problem, COPD is predicted to rank as the fifth burden of diseases in the world by 2020. Thus, prevention of exacerbations is a important goal in the management of COPD. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) Scientific Committee launched a joint project in 1998. Its goals were to raise awareness of COPD and to improve prevention and treatment of COPD patients around the world. In the 2017 GOLD guidelines, inhaled long-acting bronchodilators, including inhaled long-acting muscarinic antagonists (LAMAs) and inhaled long-acting beta-agonists (LABAs), are recommended for the management of all stable COPD patients. However, it is not known whether LABA or LAMA will be more effective for initial relief of symptoms in patients with GOLD A/B COPD. In this multicenter, randomized study, the investigators evaluate the efficacy of formoterol(LABA) and tiotropium(LAMA) in the treatment of patients with GOLD A/B COPD. The primary endpoint is postbronchodilator FEV1, and the secondary endpoints include the frequency of COPD exacerbation, other lung function parameters, CCQ score and mMRC/CAT score.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Clinical diagnosis of group A or group B stable COPD. Must be able to inhale Formoterol or Tiotropium.

Exclusion Criteria:

Asthma. Cystic fibrosis. Bronchiectasis. Lung cancer. Glaucoma. Tachyarrhythmia or other serious heart diseases. Prostatic hyperplasia.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium
inhaled Tiotropium(18µg, qd)
• Formoterol
inhaled formoterol(4.5µg, bid)

Locations

Country	Name	City	State
China	Huashan hospital,Fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postbronchodilator FEV1	a post-bronchodilator forced expiratory volume in one second	12 months
Secondary	the frequency of COPD exacerbation	the frequency of COPD exacerbation	12 months
Secondary	other lung function parameters	other lung function parameters(%FEV1, FEV1/FVC)	12 months
Secondary	CCQ score	Clinical COPD Questionnaire score	12 months
Secondary	mMRC score	modified Medical Research Council score	12 months
Secondary	CAT score	COPD Assessment Test score	12 months